A Phase 4 interventional study of enfuvirtide [Fuzeon] and enfuvirtide [Fuzeon] in HIV Infections, sponsored by Hoffmann-La Roche. Completed at 44 sites in 2 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-11-03.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 326 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: enfuvirtide [Fuzeon]
Drug: enfuvirtide [Fuzeon]
90mg sc bid by Biojector 2000 NFID for 8 weeks
90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.
Composite endpoint (pain, induration, nodules/cysts)
Time frame: Throughout study
AEs and ISRs
Time frame: Throughout study
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche